ELI-002 2P (mKRAS amphiphile) links strong T-cell response to longer RFS/OS in PDAC/CRC

ELI-002 2P is a lymph-node–targeted amphiphile vaccine (KRAS G12D/G12R peptides + CpG-7909) tested as monotherapy in MRD-positive patients after locoregional therapy in Phase 1 AMPLIFY-201 (n=25; PDAC=20, CRC=5). At 19.7-mo median follow-up, patients with ≥9.17-fold mKRAS-specific T-cell expansion had mRFS not reached vs 3.02 mo (HR 0.12; p=0.0002) and mOS not reached vs 15.98 mo (HR 0.23; p=0.0099); 71% mounted both CD4+ and CD8+ responses with 67% showing antigen spreading. Context: adjuvant mFOLFIRINOX yields DFS ~21.4 mo in resected PDAC, while postoperative ctDNA positivity portends substantially higher relapse risk—so the high-responder separation suggests biologic effect in a very high-risk niche.